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Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

FDA product code QII · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1355
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-10-07 – 2019-10-07

An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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